The Mannitol-Asthma-Ciclesonide-Study

NCT ID: NCT03839433

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-08-31

Brief Summary

Response of a 4 weeks treatment with daily once 320 µg ciclesonide on airway hyperresponsiveness assessed with mannitol.

Hypothesis: Treatment with inhaled ciclesonide reduces airway hyper-responsiveness in 80% of hyper-responsive patients compared to 20% only in the placebo group and the group without airway hyper-responsiveness.

Conditions

Asthma, Bronchial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ciclesonide positive

Half of the Mannitol positive patients were given ciclesonide. Half of the Mannitol negative patients were given ciclesonide. All patients in the "ciclesonide positive" arm received ciclesonide.

Group Type: ACTIVE_COMPARATOR

Ciclesonide

Intervention Type: DRUG

Placebo

Half of the Mannitol positive patients were given a placebo. Half of the Mannitol negative patients were given a placebo. All patients in the "placebo" arm received placebo.

Group Type: PLACEBO_COMPARATOR

Ciclesonide

Intervention Type: DRUG

Interventions

Ciclesonide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Referred to the pulmonology department of the university hospital Basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness.
• Asthma symptoms partly controlled according to GINA (Global Initiative for Asthma, October 2006) 1 week prior to randomization
• FEV1 ≥ 70% predicted

Exclusion Criteria

• Smoker and ex-smoker with >10 pack years
• COPD (chronic obstructive pulmonary disease)
• Upper respiratory tract infection within the past 4 weeks.
• ICS or oral steroids during the previous month before inclusion
• beta-blockers within the past 4 weeks
• Current treatment with medication as defined in section concomitant medication (ICS other than study medication, ß-blockers)
• Pregnancy
• Known malignancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantonal Hosptal, Baselland

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Jörg Leuppi

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

BY 9010 / CH-101

Identifier Type: -

Identifier Source: org_study_id